First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP
Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5 L/min.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005398/en/
Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire)
The first Impella ECP patient was treated by Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP including atherectomy and two one-minute long balloon inflations.
The second patient was treated at The Christ Hospital in Cincinnati by Timothy Smith, MD, an interventional cardiologist and director of cardiovascular intensive care unit, cardiogenic shock and ECMO programs. The patient had severe narrowing of the coronary arteries, including complex left main bifurcation disease and low ejection fraction. Percutaneous coronary intervention was successfully performed with support from Impella ECP.
“Ascension St. John Hospital is pleased to be the heart center leading this patient milestone as part of the early feasibility study of the smallest heart pump in the world,” said Dr. Kaki. "This new technology allows for a less invasive approach which may ultimately lead to better healing and recovery.”
“This groundbreaking technology will help more physicians provide critical hemodynamic support to patients who need it,” said Dr. Smith. “In the patient we treated, Impella ECP enabled the procedure by providing hemodynamic stability while we treated complex disease in a patient with low ejection fraction.”
Impella ECP is being studied under a U.S. Food and Drug Administration (FDA) early feasibility study. It is designed to provide temporary circulatory support and left ventricular unloading in patients undergoing a high-risk PCI. Impella ECP is delivered though a slender profile 9Fr sheath. It is un-sheathed in the descending aorta and expands. Then, using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the left ventricle. When the procedure is complete, the pump is re-sheathed back down to 9Fr and removed.
“Impella ECP is part of Abiomed’s commitment to continually innovate, patent new breakthroughs, and improve patient outcomes by developing smaller, smarter, and more connected technology,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.
The primary endpoint of the FDA early feasibility study is successful delivery, initiation and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI. The study protocol will enroll and treat up to five U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval.
Impella ECP is an investigational device, limited by federal law to investigational use only.
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD Study, STEMI DTU and Automated Impella Controller are pending trademarks of Abiomed, Inc.
Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
REPLY: Reply enters into eSports27.11.2020 09:00:00 CET | Press release
Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS
Vertex Announces European Commission Approval for SYMKEVI ® (tezacaftor/ivacaftor) With KALYDECO ® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 09:00:00 CET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O
Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 20:55:00 CET | Press release
Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti
Saudi Urban20 Chair Wishes Italy ‘Buona Fortuna’ With the 2021 Urban20 Presidency26.11.2020 14:47:00 CET | Press release
TheUrban20 (U20) Chair, His Excellency Fahd Al-Rasheed, President of the Royal Commission for Riyadh City has today wished his Italian counterparts good luck or “Buona Fortuna” as Italy prepares to take up the reins of the 2021 G20 Presidency and the engagement group of cities, the U20. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005650/en/ HE Fahd Al-Rasheed, chair of U20 Riyadh 2020 - (Photo - AETOSWire) “The city of Riyadh is immensely proud and honored to have Chaired the 2020 U20. We are proud of the progress we made together as the U20 of 42 cities and 30 think tanks, universities, and multi-lateral entities. We collaborated, innovated and found common ground. We discussed challenges and solutions experienced by cities across every continent. We focused on the common goal of rebuilding better. As we worked to bring urban issues to the fore, a record 39 mayors and representatives of leading cities endorsed the
DEWA Innovation Centre and 800MW 3rd Phase of the Mohammed bin Rashid Al Maktoum Solar Park Inaugurated26.11.2020 14:31:00 CET | Press release
HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, has inaugurated Dubai Electricity and Water Authority’s (DEWA’s) Innovation Centre and the 800MW third phase of the Mohammed bin Rashid Al Maktoum Solar Park, the largest single-site solar park in the world. The solar park has a planned capacity of 5,000MW by 2030, with investments up to AED50 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005645/en/ DEWA Innovation Centre and 800MW 3rd phase of the Mohammed bin Rashid Al Maktoum Solar Park inaugurated (Photo: AETOSWire) HH Sheikh Mohammed bin Rashid Al Maktoum was briefed by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA, about the Innovation Centre, which is a global hub for renewable and clean energy innovation. It supports innovation and creativity in clean and renewable energy, promotes sustainability, develops Emirati talent and enhances the UAE’s com
Leveraging Its Mobile ID, IDEMIA Brings Digital Travel Credentials to Life26.11.2020 14:30:00 CET | Press release
Digital Travel Credentials make traveling between airports and airlines a more enjoyable experience and bolsters passenger trust in airport services and systems. On 10-11 November 2020, at the ICAO virtual conference, IDEMIA demonstrated with an airline partner its breakthrough innovation capabilities to present a fully operational solution, bringing DTC to life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005534/en/ (Photo: Buiness Wire) Leveraging its Mobile ID solution and passenger flow facilitation solutions, IDEMIA simulated a passenger DTC for check in and smart boarding. Passengers can speed through all airport touchpoints thanks to fast and ultra-secure biometric identification. IDEMIA’s DTC treat private data with the same security level as for paper passports. “This DTC demonstrator illustrates the innovative capabilities of IDEMIA to perform a highly secure, reliable and smooth identity verification of t
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom